This trial is active, not recruiting.

Condition relapsing remitting multiple sclerosis
Treatments glatiramer acetate (ga), placebo
Phase phase 3
Sponsor Teva Pharmaceutical Industries
Start date May 2010
End date December 2016
Trial size 1404 participants
Trial identifier NCT01067521, 2009-018084-27, MS-GA-301


The study is designed to assess the efficacy of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in subjects with RRMS, as measured by the number of confirmed relapses during the 12 month placebo controlled phase. The study has two phases:

- Placebo Controlled Phase: 12 months of 40 mg administered three times a week by subcutaneous injection or matching placebo.

- Open Label Extension: All subjects will continue treatment with GA 40 mg administered three times a week, until this dose strength is commercially available for the treatment of relapsing remitting multiple sclerosis (RRMS) patients or until the development of this GA dose regimen is stopped by the Sponsor

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
glatiramer acetate (ga)
GA 40 mg administered 3 times a week by subcutaneous injection for a period of 12 months
(Placebo Comparator)
Placebo comparator

Primary Outcomes

The total number of confirmed relapses during the 12 month PC phase
time frame: 12 months

Secondary Outcomes

The number of new T2 lesions at month 12 (end of PC phase) as compared to baseline scan.
time frame: 12 months
The cumulative number of enhancing lesions on T1-weighted images taken at months 6 and 12 (end of PC phase).
time frame: 12 months
Status of Gd-enhancing T1 activity at baseline
time frame: Baseline

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

Inclusion Criteria: 1. Subjects must have a confirmed and documented MS diagnosis as defined by the Revised McDonald criteria with a relapsing-remitting disease course. 2. Subjects must be ambulatory with an EDSS score of 0-5.5 in both screening and baseline visits. 3. Subjects must be in a relapse-free, stable neurological condition and free of corticosteroid treatment [intravenous (IV), intramuscular (IM) and/or per os (PO)] or ACTH 30 days prior to screening (month -1) and between screening and baseline (month 0) visits. 4. Subjects must have experienced one of the following: At least one documented relapse in the 12 months prior to screening, or At least two documented relapses in the 24 months prior to screening, or One documented relapse between 12 and 24 months prior to screening with at least one documented T1-Gd enhancing lesion in an MRI performed within 12 months prior to screening. 5. Subjects must be between 18 and 55 years of age, inclusive. 6. Women of child-bearing potential must practice an acceptable method of birth control. 7. Subjects must be able to sign and date a written informed consent prior to entering the study. 8. Subjects must be willing and able to comply with the protocol requirements for the duration of the study Exclusion Criteria: 1. Subjects with progressive forms of MS. 2. Use of experimental or investigational drugs, and/or participation in drug clinical studies within the 6 months prior to screening. 3. Use of immunosuppressive (including Mitoxantrone and Fingolimod) or cytotoxic agents within 6 months prior to the screening visit. 4. Use of natalizumab (Tysabri®) or any other monoclonal antibodies within 2 years prior to screening. 5. Use of cladribine within 2 years prior to screening. 6. Previous treatment with immunomodulators (including IFNβ 1a and 1b, and IV Immunoglobulin (IVIg) within 2 months prior to screening. 7. Previous use of GA or any other glatiramoid. 8. Chronic (more than 30 consecutive days) systemic (IV, PO or IM) corticosteroid treatment within 6 months prior to screening visit. 9. Previous total body irradiation or total lymphoid irradiation. 10. Previous stem-cell treatment, autologous bone marrow transplantation or allogenic bone marrow transplantation. 11. Pregnancy or breastfeeding. 12. Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation, as determined by medical history, physical exams, ECG, abnormal laboratory tests and chest X-ray. Such conditions may include hepatic, renal or metabolic diseases, systemic disease, acute infection, current malignancy or recent history (5 years) of malignancy, major psychiatric disorder, history of drug and/or alcohol abuse and allergies that could be detrimental according to the investigator's judgment. 13. A known history of sensitivity to Gadolinium. 14. Inability to successfully undergo MRI scanning. 15. A known drug hypersensitivity to Mannitol.

Additional Information

Official title A Multinational, Multicenter, Randomized, Parallel-group Study in Subjects With Relapsing-Remitting Multiple Sclerosis to Assess Efficacy, Safety and Tolerability of Glatiramer Acetate Injection 40mg Compared to Placebo in a Double-blind Design
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Teva Pharmaceutical Industries.